Quantient Sciences, a CDMO specializing in “niche, low-volume” medicines that are often overlooked by larger contract manufacturers, has extended its contract with Ipsen to manufacture Sohonos (Parovalotene) capsules.
Sohonos is currently the only drug approved by the FDA to treat the ultra-rare disease fibrodysplasia ossificans progressiva (FOP).
FOP is a progressive genetic disease in which bone gradually replaces muscle and connective tissue on the outside of the skeleton. This can restrict movement and cause loss of mobility over time. Quotient said in a Feb. 26 press release that fewer than 1,000 people worldwide are affected by the condition.
As for Sohonos, Quotient explained that the drug (a retinoic acid receptor gamma agonist approved by the FDA in 2023) is so potent that it requires “special handling and containment” to protect both the production facility and the operators.
Financial details of the deal were not disclosed, but Ibsen invested in new equipment for the trading company’s manufacturing facility in Boothwyn, Pennsylvania, including a pneumatically sealed transfer system that allows for safe material transfer without affecting blend separation, the trading company said.
The cash injection from Ipsen is also supporting a new flexible dispensing isolator that improves operator employee safety and eliminates certain cleaning requirements, Cootient added.
The expanded team-up with Ipsen will enhance the trading company’s ability to handle and produce highly potent API drug molecules and products, according to a CDMO release.
“By expanding our capacity for highly potent compounds, we are not only ensuring a reliable supply of critical treatments like Sohonos (parovarotene) for the FOP community, but also strengthening our commitment to providing flexible, high-quality solutions to partners with special needs, especially for highly potent compounds,” Marlene Leuenberger, vice president and general manager of Quotient Philadelphia, said in a statement.
Ibsen is not alone in developing treatments for FOP.
Just a few weeks ago, Regeneron announced that the FDA had granted priority BLA review for garetosumab, also for rare diseases. The filing follows the completion last fall of a pivotal Phase 3 trial in which the drug reduced bone lesions by more than 90% in patients treated with it.
The company said in February that it expected the FDA to issue an approval decision in August.
